Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma

NCT ID: NCT03002402

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-07-17

Brief Summary

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The purpose of the proposed study are to explore changes in sleep and asthma outcomes from baseline to post-treatment in adults with asthma and comorbid insomnia who underwent Internet-based cognitive-behavioral treatment for insomnia (CBT-I).

Detailed Description

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Conditions

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Asthma Insomnia Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internet-based CBT-I

Sleep Healthy Using the Internet (SHUTi) is a self-guided, automated, interactive, and tailored web-based program modeled on the primary tenets of cognitive-behavioral treatment for insomnia (CBT-I): sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is allocated out over time through 6 "Cores." Users obtain access to a new Core based on a time and event-based schedule (e.g., 7 days after completion of previous Core). SHUTi uses online sleep diaries to track progress and to tailor treatment (e.g., assign a sleep restriction window).

Group Type EXPERIMENTAL

Internet-based CBT-I

Intervention Type BEHAVIORAL

Internet-based cognitive-behavioral treatment for insomnia

Interventions

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Internet-based CBT-I

Internet-based cognitive-behavioral treatment for insomnia

Intervention Type BEHAVIORAL

Other Intervention Names

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Sleep Healthy Using the Internet (SHUTi)

Eligibility Criteria

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Inclusion Criteria

* Primary diagnosis of moderate-severe persistent asthma
* Not well controlled asthma (score ≤ 19 on the Asthma Control Test)
* Age 18-75 years
* Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Insomnia Disorder
* At least moderate insomnia severity (score ≥ 10 on Insomnia Severity Index)
* Telephone number, email address, and reliable Internet access

Exclusion Criteria

* History of bipolar or psychosis
* Substance abuse disorder within past 3 months
* Dementia or probable dementia diagnosis
* Plans to move or leave present source of care during the following 6 months.
* Non-English speaking, illiterate, or possesses sensory deficits
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Faith Luyster

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Faith S Luyster, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1R03HL135213-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R03HL135213-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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